NOTICE - COMMON POSITION ADOPTED BY THE COUNCIL IN ACCORDANCE WITH THE COOPERATION PROCEDURE LAID DOWN IN ARTICLE 149 ( 2 ) OF THE EEC TREATY: PROPOSAL FOR A COUNCIL DIRECTIVE EXTENDING THE SCOPE OF DIRECTIVES 65/65/EEC AND 75/319/EEC ON THE APPROXIMATION OF PROVISIONS LAID DOWN BY LAW, REGULATION OR ADMINISTRATIVE ACTION RELATING TO PROPRIETARY MEDICINAL PRODUCTS AND LAYING DOWN ADDITIONAL PROVISIONS FOR IMMUNOLOGICAL MEDICINAL PRODUCTS AND CONSISTING OF VACCINES, TOXINS OR SERUMS AND ALLERGENS

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Official report CELEX 51989AG0120(02) from European Union at Council of the European Union. Dated 20 January 1989. Status: open.

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• NOTICE - COMMON POSITION ADOPTED BY THE COUNCIL IN ACCORDANCE WITH THE COOPERATION PROCEDURE LAID DOWN IN ARTICLE 149 ( 2 ) OF THE EEC TREATY: PROPOSAL FOR A COUNCIL DIRECTIVE EXTENDING THE SCOPE OF DIRECTIVES 65/65/EEC AND 75/319/EEC ON THE APPROXIMATION OF PROVISIONS LAID DOWN BY LAW, REGULATION OR ADMINISTRATIVE ACTION RELATING TO PROPRIETARY MEDICINAL PRODUCTS AND LAYING DOWN ADDITIONAL PROVISIONS FOR IMMUNOLOGICAL MEDICINAL PRODUCTS AND CONSISTING OF VACCINES, TOXINS OR SERUMS AND ALLERGENS

  preparatory · EN · 20 January 1989

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• Γνώμη - Διαμόρφωση κοινής θέσης από το Συμβούλιο στα πλαίσια της διαδικασίας συνεργασίας που προβλέπεται στο άρθρο 149 παράγραφος 2 της συνθήκης για την ίδρυση της ΕΟΚ: Πρόταση οδηγίας του Συμβουλίου που επεκτείνει το πεδίο εφαρμογής των οδηγιών 65/65/ΕΟΚ και 75/319/ΕΟΚ για την προσέγγιση των νομοθετικών, κανονιστικών και διοικητικών διατάξεων σχετικά με τα φαρμακευτικά ιδιοσκευάσματα και θεσπίζει πρόσθετες διατάξεις για τα ανοσολογικά φαρμακευτικά προϊόντα που συνίστανται σε εμβόλια, τοξίνες ή ορούς και αλλεργιογόνα

  preparatory · EL · 20 January 1989

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• AVISO-ELABORACAO DE UMA POSICAO COMUM DO CONSELHO NO AMBITO DO PROCESSO DE COOPERACAO PREVISTO NO NO 2 DO ARTIGO 149 DO TRATADO A COMUNIDADE ECONOMICA EUROPEIA: PROPOSTAS DE DIRECTIVA DO CONSELHO QUE ALARGA O AMBITO DE APLICACAO DAS DIRECTIVAS 65/65/CEE E 75/319/CEE RELATIVAS A APROXIMACAO DAS DISPOSICOES LEGISLATIVAS, REGULAMENTARES E ADMINISTRATIVAS RESPEITANTES AS ESPECIALIDADES FARMACEUTICAS E QUE ESTABELECE DISPOSICOES COMPLEMENTARES PARA MEDICAMENTOS IMUNOLOGICOS QUE CONSISTAM EM VACINAS, TOXINAS OU SOROS E ALERGENIOS

  preparatory · PT · 20 January 1989

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• AVISO-ESTABLECIMIENTO POR PARTE DEL CONSEJO DE UNA POSICION COMUN, EN EL MARCO DEL PROCEDIMIENTO DE COOPERACION PREVISTO POR EL APARTADO 2 DEL ARTICULO 149 DEL TRATATO DE LA CEE: PROPUESTA DE DIRECTIVA DEL CONSEJO POR LA QUE SE AMPLIA EL AMBITO DE APLICACION DE LAS DIRECTIVAS 65/65/CEE Y 75/319/CEE RELATIVAS A LA APROXIMACION DE LAS DISPOSICIONES LEGALES, REGLAMENTARIAS Y ADMINISTRATIVAS SOBRE LAS ESPECIALIDADES FARMACEUTICAS, Y POR LA QUE SE ADOPTAN DISPOSICIONES COMPLEMENTARIAS SOBRE MEDICAMENTOS IMMUNOLOGICOS CONSISTENTES EN VACUNAS, TOXINAS, SUEROS Y ALERGENOS

  preparatory · ES · 20 January 1989

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• BEKANNTMACHUNG-FESTLEGUNG GEMEINSAME STANDPUNKT DURCH DEN RAT IM RAHMEN DES IN ARTIKEL 149 ABSATZ 2 DES VERTAGES ZUR GRUENDUNG DER EWG VORGESEHENEN VERFAHRENS DER ZUSAMMENARBEIT: VORSCHLAG FUER EINE RICHTLINIE DES RATES ZUR ERWEITERUNG DES ANWENDUNGSBEREICHS DER RICHTLINIEN 65/65/EWG UND 75/319/EWG ZUR ANGLEICHUNG DER RECHTS- UND VERWALTUNGSVORSCHRIFTEN UEBER ARZNEISPEZIALITAETEN UND ZUR FESTLEGUNG ZUSAETZLICHER VORSCHRIFTEN FUER AUS IMPFSTOFFEN, TOXINEN ODER SEREN UND ALLERGENEN BESTEHENDE IMMUNOLOGISCHE ARZNEIMITTEL

  preparatory · DE · 20 January 1989

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• AVVISO-ELABORAZIONE DA PARTE DEL CONSIGLIO DI UNA POSIZIONE COMUNE NEL QUADRO DELLA PROCEDURA DI COOPERAZIONE PREVISTA DALL' ARTICOLO 149, PARAGRAFO 2 DEL TRATTATO CHE ISTITUISCE LA CEE: PROPOSTA DI DIRETTIVA DEL CONSIGLIO CHE ESTENDE IL CAMPO DI APPLICAZIONE DELLE DIRETTIVE 65/65/CEE E 75/319/CEE PER IL RAVVICINAMENTO DELLE DISPOSIZIONI LEGISLATIVE, REGOLAMENTARI ED AMMINISTRATIVE RELATIVE ALLE SPECIALITA MEDICINALI E CHE PREVEDE NORME AGGIUNTIVE PER I MEDICINALI IMMUNOLOGICI COSTITUITI DA VACCINI, TOSSINE, SIERI O ALLERGENI

  preparatory · IT · 20 January 1989

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• BERICHT-VASTSTELLING DOOR DE RAAD VAN GEMEENSCHAPPELIJK STANDPUNT IN HET KADER VAN DE SAMENWERKINGSPROCEDURE VAN ARTIKEL 149, LID 2, VAN HET VERDRAG TOT OPRICHTING VAN DE EUROPESE ECONOMISCHE GEMEENSCHAP: VOORSTEL VOOR EEN RICHTLIJN VAN DE RAAD TOT UITBREIDING VAN DE WERKINGSSFEER VAN DE RICHTLIJNEN 65/65/EEG EN 75/319/EEG BETREFFENDE DE AANPASSING VAN WETTELIJKE EN BESTUURSRECHTELIJKE BEPALINGEN INZAKE FARMACEUTISCHE SPECIALITEITEN EN TOT VASTSTELLING VAN BIJKOMENDE BEPALINGEN VOOR IMMUNOLOGISCHE GENEESMIDDELEN BESTAANDE UIT VACCINS, TOXINEN, SERUMS OF ALLERGENEN

  preparatory · NL · 20 January 1989

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• MEDDELELSE - FAELLES HOLDNING FASTLAG AF RAADET INDEN FOR RAMMERNE AF SAMARBEJDSPROCEDUREN I HENHOLD TIL ARTIKEL 149, STK. 2, I TRAKTATEN OM OPRETTELSE AF DET EUROPAEISKE OEKONOMISKE FAELLESSKAB: FORSLAG TIL RAADETS DIREKTIV OM UDVIDELSE AF ANVENDELSESOMRAADET FOR DIREKTIV 65/65/EOEF OG 75/319/EOEF OM INDBYRDES TILNAERMELSE AF LOVGIVNING OM FARMACEUTISKE SPECIALITETER OG OM FASTSAETTELSE AF SUPPLERENDE BESTEMMELSER FOR IMMUNOLOGISKE LAEGEMIDLER I FORM AF VACCINER, TOKSINER, SERA OG ALLERGENER

  preparatory · DA · 20 January 1989

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• AVIS-ETABLISSEMENT PAR LE CONSEIL D' UNE POSITION COMMUNE DANS LE CADRE DE LA PROCEDURE DE COOPERATION PREVUE PAR L' ARTICLE 149 PARAGRAPHE 2 DU TRAITE INSTITUANT LA COMMUNAUTE ECONOMIQUE EUROPEENNE: PROPOSITION DE DIRECTIVE DU CONSEIL ELARGISSANT LE CHAMP D' APPLICATION DES DIRECTIVES 65/65/CEE ET 75/319/CEE CONCERNANT LE RAPPROCHEMENT DES DISPOSITIONS LEGISLATIVES, REGLEMENTAIRES ET ADMINISTRATIVES RELATIVES AUX SPECIALITES PHARMACEUTIQUES ET PREVOYANT DES DISPOSITIONS COMPLEMENTAIRES POUR LES MEDICAMENTS IMMUNOLOGIQUES CONSISTANT EN VACCINS, TOXINES, SERUMS OU ALLERGENES

  preparatory · FR · 20 January 1989

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